Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K240775
Device Name PeriBeam® Pericardial Membrane
Applicant
Tamabio
#402 2-2-18 Sakai Mushashino-Shi
Tokyo,  JP 180-0022
Applicant Contact Tetsuya Nagao
Correspondent
Nilo Medical Consulting Group, LLC
3491 Denny St.
#313
Pisstburgh,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received03/21/2024
Decision Date 04/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-